510(k) · Cleared
ClearedLTV2 Series Ventilators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vyaire Medical, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Nov 10, 2021 as substantially equivalent to K060647 (Pulmonetic Systems, Inc., 2006) and 1 other predicate after a 566-day review. Its family tree reaches back 9 generations to 1991. 5 of the 53 devices in its family, counting itself, have a Class I recall.
- Decided
- Nov 10, 2021
- Review
- 566 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K902859 (1991). 52 ancestors in all, the oldest K895541 (1990). No later device cites it as a predicate yet. 5 of the 53 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 5 generations between
- 3 generations backK060647 LTV 1200 VentilatorPulmonetic Systems, Inc. · 2006
- 2 generations backK093094 Vela VentilatorCardinal Health 207, Inc. · 2010
- 1 generation backK101643 Model LTV 1100 VentilatorCare Fusion · 2011
- This deviceK201082 LTV2 Series VentilatorsVyaire Medical, Inc. · 2021
Show all 9 generations
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 8 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 7 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 6 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 5 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 4 generations backK022674 Bird Avea VentilatorBird Products Corp. · 2002 · Recalled
- 3 generations backK060647 LTV 1200 VentilatorPulmonetic Systems, Inc. · 2006
- 2 generations backK093094 Vela VentilatorCardinal Health 207, Inc. · 2010
- 1 generation backK101643 Model LTV 1100 VentilatorCare Fusion · 2011
- This deviceK201082 LTV2 Series VentilatorsVyaire Medical, Inc. · 2021
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −8 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −7 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −6 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −5 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −4 | K022674 | Bird Avea Ventilator | Bird Products Corp. | 2002 | 5 |
| −3 | K060647 | LTV 1200 Ventilator | Pulmonetic Systems, Inc. | 2006 | — |
| −2 | K093094 | Vela Ventilator | Cardinal Health 207, Inc. | 2010 | — |
| −1 | K101643 | Model LTV 1100 Ventilator | Care Fusion | 2011 | — |
| 0 (this device) | K201082 | LTV2 Series Ventilators | Vyaire Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 8 | 1 |
| 1999 | 4 | 0 |
| 2000 | 3 | 1 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 1 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
5 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060647 | LTV 1200 VentilatorSummary page 4…t Code: CBK 3. Predicate Device [21 CFR § 807.92(a)(3)] This submission demonstrates substantial equivalence to the LTV 1200 Ventilator K060647 cleared on May 25th, 2006 and LTV 1100 cleared under K101643 on January 26th, 2011. Ta… | 2006 |
| * | K101643 | Model LTV 1100 VentilatorSummary page 4…2(a)(3)] This submission demonstrates substantial equivalence to the LTV 1200 Ventilator K060647 cleared on May 25th, 2006 and LTV 1100 cleared under K101643 on January 26th, 2011. Table 1: Predicate Device Information… | 2011 |
| † | K032451 | Bird Tbird Vela Ventilator | 2004 |
| † | K070594 | Palmtop Ventilator, Models PTV-8, PTV-10 | 2007 |
| † | K183364 | Bellavista | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073069Modification to Avea VentilatorViasys Respiratory Care, Inc. · 2008 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 113 Class I recalls
- K013642AVEABird Products Corp. · 2002 · 3 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 8 companies; a new generation was cleared every 2.7 years on median.
- 19 of the 52 ancestors have a recall of any class; 5 have a Class I recall.
- 8 other devices also cite its predicate K060647.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
LTV2 model 2200 and 2150 ventilators are intended to provide continuous or intermittent ventilator support for the
care of the individuals who require mechanical ventilation. The use environment is for institutional use.
Institutional use includes ICU or other hospital environments including intra-hospital transport. The model 2200
can operate with high pressure O2. The model 2150 operates with low pressure oxygen.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201082 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201082: LTV2 Series Ventilators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201082
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026